Outrage Over Pregnancy Drug Price Hike May Force Change

As we’vebeenreporting, the new price of the prematurity-preventing drug Makena — which went from about $10 a dose to $1,500 after the branded drug was approved and replaced existing low-cost medications made by various specialty pharmacies — has generated a wave of anger, with doctors and politicians calling for change.

Now, the Saint Louis Post-Dispatchsays the backlash may be having an impact:

In a securities filing on Tuesday, KV Pharmacuetical Co. acknowledged that it had received a torrent of criticism over the high price of its newly approved prenatal drug, Makena, and that it could face challenges in getting the government and insurance companies to pay.

Senators Sherrod Brown (D-Ohio) and Amy Klobuchar (D-Minn.) have demanded an investigation of the pricing by the Federal Trade Commission, and in questioning FDA Commissioner Margaret Hamburg about the matter, Brown said that the increase “looks a lot like blackmail to me.”

In a statement on its website, KV said, “We recognize the concerns that have been raised regarding the list price, patient access, and potential cost to payers…we have heard clearly from various stakeholders that we need to do more because the cost of therapy remains a significant concern.”

Makena, a form of progesterone, has been shown to reduce the odds of premature birth by about 33%. Premature birth affects one in eight pregnancies — and can cause major, lifelong disabilities. It adds $26 billion to medical costs each year.

It was previously sold by compounding pharmacies, which made the product to order. The medication had been on the market for more than 40 years, and compounding pharmacies were allowed to sell it because it had received FDA approval as safe — before the agency changed its approval rules to require evidence of both safety and effectiveness. Recent research funded by the government demonstrated that it does reduce premature birth, and this allowed KV to seek new FDA approval for a consistent, branded product to replace the compounded version.

KV offers the drug to women without insurance at the lower price, but the company sought to have insurers and cash-strapped federal agencies like Medicaid pay far more. The question now is whether moral outrage or greed will triumph.